Mektovi

Name: Mektovi

Indications and Usage for Mektovi

Mektovi® is indicated, in combination with encorafenib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test [see Dosage and Administration (2.1)].

Dosage Forms and Strengths

Tablets: 15 mg, yellow/dark yellow, unscored biconvex oval film-coated tablets debossed with a stylized "A" on one side and "15" on the other side.

Overdosage

Since binimetinib is 97% bound to plasma proteins, hemodialysis is likely to be ineffective in the treatment of overdose with Mektovi.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenicity studies with binimetinib have not been conducted. Binimetinib was not genotoxic in studies evaluating reverse mutations in bacteria, chromosomal aberrations in mammalian cells, or micronuclei in bone marrow of rats.

No dedicated fertility studies have been conducted with binimetinib in animals. In general toxicology studies in rats and monkeys, there were no remarkable findings in male or female reproductive organs.

How Supplied/Storage and Handling

Mektovi (binimetinib) is supplied as 15 mg yellow/dark yellow, unscored biconvex oval film-coated tablets debossed with a stylized "A" on one side and "15" on the other side, available in bottles of 180 tablets (NDC 70255-010-02).

Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature].

Patient Counseling Information

Advise the patient to read the FDA-approved patient labeling (Patient Information).

Inform patients of the following:

Cardiomyopathy

Advise patients to report any symptoms of heart failure to their healthcare provider [see Warnings and Precautions (5.1)].

Venous Thrombosis

Advise patients to contact their healthcare provider if they experience symptoms of venous thrombosis or pulmonary embolism. Advise patients to seek medical attention for sudden onset of difficulty breathing, leg pain, or swelling [see Warnings and Precautions (5.2)].

Ocular Toxicities

Advise patients to contact their healthcare provider if they experience any changes in their vision [see Warnings and Precautions (5.3)].

Interstitial Lung Disease

Advise patients to contact their healthcare provider if they experience any new or worsening respiratory symptoms including cough or dyspnea [see Warnings and Precautions (5.4)].

Hepatotoxicity

Advise patients that serial testing of serum liver tests (ALT, AST, bilirubin) is recommended during treatment with Mektovi. Instruct patients to report symptoms of liver dysfunction including jaundice, dark urine, nausea, vomiting, loss of appetite, fatigue, bruising, or bleeding [see Warnings and Precautions (5.5)].

Rhabdomyolysis

Advise patients to contact their healthcare provider as soon as possible if they experience unusual or new onset weakness, myalgia, or darkened urine [see Warnings and Precautions (5.6)].

Hemorrhage

Advise patients to notify their healthcare provider if they experience symptoms suggestive of hemorrhage, such as unusual bleeding [see Warnings and Precautions (5.7)].

Females and Males of Reproductive Potential

Embryo-Fetal Toxicity: Advise females with reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with Mektovi and for 30 days after the final dose. Advise females to contact their healthcare provider if they become pregnant, or if pregnancy is suspected, during treatment with Mektovi [see Warnings and Precautions (5.8), Use in Specific Populations (8.1)].

Lactation: Advise women not to breastfeed during treatment with Mektovi and for 3 days after the final dose [see Use in Specific Populations (8.2)].

Distributed by:
Array BioPharma Inc.
3200 Walnut Street
Boulder, CO 80301

© 2018 Array BioPharma Inc. All rights reserved.
Mektovi® is a registered trademark of Array BioPharma Inc. in the United States and various other countries.
Patented. See www.arraybiopharma.com/patents

This Patient Information has been approved by the U.S. Food and Drug Administration. Issued: June 2018
PATIENT INFORMATION
Mektovi® (mek-TOE-vee)
(binimetinib)
tablets
Important Information: If your healthcare provider prescribes Mektovi with encorafenib, please read the Medication Guide that comes with encorafenib.
What is Mektovi?
Mektovi is a prescription medicine used in combination with a medicine called encorafenib to treat people with a type of skin cancer called melanoma:
  • that has spread to other parts of the body or cannot be removed by surgery, and
  • that has a certain type of abnormal "BRAF" gene
Your healthcare provider will perform a test to make sure that Mektovi is right for you.
It is not known if Mektovi is safe and effective in children.
Before taking Mektovi, tell your healthcare provider about all of your medical conditions, including if you:
  • have heart problems
  • have had blood clots
  • have eye problems
  • have lung or breathing problems
  • have liver or kidney problems
  • have any muscle problems
  • have bleeding problems
  • have high blood pressure (hypertension)
  • are pregnant or plan to become pregnant. Mektovi can harm your unborn baby.
    • Females who are able to become pregnant should use effective birth control (contraception) during treatment with Mektovi and for at least 30 days after the final dose of Mektovi.
    • Talk to your healthcare provider about birth control methods that may be right for you during this time.
    • Your healthcare provider will do a pregnancy test before you start taking Mektovi. Tell your healthcare provider right away if you become pregnant or think you might be pregnant during treatment with Mektovi.
  • are breastfeeding or plan to breastfeed. It is not known if Mektovi passes into your breast milk. Do not breastfeed during treatment with Mektovi and for 3 days after the final dose of Mektovi. Talk to your healthcare provider about the best way to feed your baby during this time.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.
How should I take Mektovi?
  • Take Mektovi exactly as your healthcare provider tells you to take it. Do not change your dose or stop taking Mektovi unless your healthcare provider tells you to.
  • Your healthcare provider may change your dose of Mektovi, temporarily stop, or completely stop your treatment with Mektovi if you develop certain side effects.
  • Take Mektovi in combination with encorafenib by mouth 2 times a day, about 12 hours apart.
  • Mektovi may be taken with or without food.
  • If you miss a dose of Mektovi, take it as soon as you remember. If it is within 6 hours of your next scheduled dose, take your next dose at your regular time. Do not make up for the missed dose.
  • Do not take an extra dose if you vomit after taking your scheduled dose. Take your next dose at your regular time.
  • If you stop treatment with encorafenib, talk to your healthcare provider about whether your Mektovi treatment may need to be stopped.
What are the possible side effects of Mektovi?
Mektovi may cause serious side effects, including:
  • Heart problems, including heart failure. Your healthcare provider should check your heart function before and during treatment with Mektovi. Call your healthcare provider right away if you have any of the following signs and symptoms of a heart problem:
    • feeling like your heart is pounding or racing
    • shortness of breath
    • swelling of your ankles and feet
    • feeling lightheaded
  • Blood clots. Mektovi can cause blood clots in your arms or legs, which can travel to your lungs and can lead to death. Get medical help right away if you have the following symptoms:
    • chest pain
    • sudden shortness of breath or trouble breathing
    • pain in your legs with or without swelling
    • swelling in your arms and legs
    • a cool pale arm or leg
  • Eye problems. Mektovi can cause serious eye problems that might lead to blindness. Call your healthcare provider right away if you develop any of these symptoms of eye problems:
    • blurred vision, loss of vision, or other vision changes
    • see colored dots
    • see halos (blurred outline around objects)
    • eye pain, swelling, or redness
  • Lung or breathing problems. Mektovi can cause lung or breathing problems. Tell your healthcare provider if you have any new or worsening symptoms of lung or breathing problems, including:
    • shortness of breath
    • cough
  • Liver problems. Your healthcare provider should perform blood tests to check your liver function before and during treatment with Mektovi. Tell your healthcare provider if you have any of the following signs and symptoms of a liver problem:
    • yellowing of your skin or the white part of your eyes (jaundice)
    • dark or brown (tea-colored) urine
    • nausea or vomiting
    • loss of appetite
  • Muscle problems (rhabdomyolysis). Mektovi can cause muscle problems that can be severe. Treatment with Mektovi may increase the level of an enzyme in your blood called creatine phosphokinase (CPK) and can be a sign of muscle damage. Your healthcare provider should perform a blood test to check your levels of CPK before and during treatment. Tell your healthcare provider right away if you develop any of these symptoms:
    • weakness
    • muscle aches or pain
    • dark, reddish urine
  • Bleeding problems. Mektovi, when taken with encorafenib, can cause serious bleeding problems, including in your brain or stomach, that can lead to death. Call your healthcare provider and get medical help right away if you have any signs of bleeding, including:
    • headaches, dizziness, or feeling weak
    • cough up blood or blood clots
    • vomit blood or your vomit looks like "coffee grounds"
    • red or black stool that look like tar
The most common side effects of Mektovi when taken with encorafenib, include:
  • fatigue
  • nausea
  • diarrhea
  • vomiting
  • abdominal pain
These are not all the possible side effects of Mektovi.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
You may also report side effects to Array BioPharma Inc. at 1-844-792-7729.
How should I store Mektovi?
  • Store Mektovi at room temperature between 68°F to 77°F (20°C to 25°C).
Keep Mektovi and all medicines out of the reach of children.
General information about the safe and effective use of Mektovi.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Mektovi for a condition for which it was not prescribed. Do not give Mektovi to other people, even if they have the same symptoms that you have. It may harm them. You can ask your healthcare provider or pharmacist for information about Mektovi that is written for health professionals.
What are the ingredients in Mektovi?
Active ingredient: binimetinib
Inactive ingredients: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, magnesium stearate (vegetable source), and colloidal silicon dioxide
Tablet coating: polyvinyl alcohol, polyethylene glycol, titanium dioxide, talc, ferric oxide yellow, ferrosoferric oxide
Distributed by: Array BioPharma Inc. Boulder, Colorado 80301.
Mektovi® is a registered trademark of Array BioPharma Inc. in the United States and various other countries.
For more information, go to www.BRAFTOVIMektovi.com or call 1-844-792-7729.
©2018 Array BioPharma Inc. All rights reserved.

What are some other side effects of Mektovi?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Upset stomach or throwing up.
  • Feeling tired or weak.
  • Loose stools (diarrhea).
  • Belly pain.
  • Hard stools (constipation).
  • Dizziness.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Actions

Specific Drugs

It is essential that the manufacturer's labeling be consulted for more detailed information on interactions with this drug, including possible dosage adjustments. Interaction highlights:

No clinically important drug interactions have been observed with binimetinib.1

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Binimetinib

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Tablet, Film Coated

15 mg

Mektovi

Array BioPharma Inc.

Medical Disclaimer

Before Using Mektovi

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of binimetinib in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of binimetinib in the elderly.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Bleeding problems or
  • Blood clots (eg, deep vein thrombosis, pulmonary embolism) or
  • Eye or vision problems or
  • Heart disease (eg, cardiomyopathy, heart failure) or
  • Hypertension (high blood pressure) or
  • Lung disease or breathing problems or
  • Muscle problems—Use with caution. May make these conditions worse.
  • Liver disease, moderate or severe—Use with caution. The effects may be increased because of the slower removal of the medicine from the body.

Mektovi Dosage

Your doctor will perform blood tests to make sure you have the correct tumor type to be treated with binimetinib.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Binimetinib is usually taken twice per day (every 12 hours), with or without food.

Do not change your dose or dosing schedule without your doctor's advice.

If you vomit shortly after taking binimetinib, do not take another dose. Wait until your next scheduled dose time to take the medicine again.

You will need frequent medical tests.

Store at room temperature away from moisture and heat.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Take the medicine as soon as you can, but skip the missed dose if your next dose is due in less than 6 hours. Do not use two doses at one time.

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